2017 PDA Regulatory Comments

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Parenteral Drug Association Connecting People, Science and Regulation ^®

PDA Response to WHO Draft Guidlines on Procedures and Data Requirement for PAC Biotherapeutics 15 Sep 2017

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PDA Response to EMA Concept Paper on Need for Revision of Note for Guideline on Water for Pharmaceutical Use 6 Jun 2017

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PDA Response to CFDA Draft Guidance on Simulation Testing of Sterile Processes 7 Sep 2017

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PDA Response to FDA Interchangeability Draft Guidance on Human Factors 20 Jun 2017

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PDA Response to EMA Q and A for Shared Facilities and HBEL Limits 30 May 2017

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PDA Response to Health Canada Draft Guidance on GMPs for Drug Products 1 May 2017

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PDA Response to FDA Draft Guidance on Comparative HF Studies Drug Device Combo Products for ANDA 31 Mar 2017

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PDA Response to FDA Revised Draft Guidance on Quality Metrics 27 Mar 2017

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PDA Response to CFDA Draft Guidance on Drug Data Management 9 Mar 2017

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